Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia

• Sponsor: Sakarya University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04432181
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

the records of astigmatic children were reviewed and any deviation was investigated at near and distance. refractive errors, stereopsis, convergence insufficiency were also evaluated. children were divided into two groups according to the presence of amblyopia and ocular deviations and other parameters were compared between groups.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism of Both Eyes; Amblyopia; Strabismus	Other: ophthalmic examination

Detailed Description

The aim of the study was to evaluate deviations in children with ≥1,75 diopter (D) astigmatism with or without amblyopia.

The records of children with ≥1,75 D astigmatism were investigated. Subjects with and without amblyopia composed group 1 and 2, respectively. The mean age, gender, amount and type of deviation, presence of convergence insufficiency (CI), stereopsis, time of initial spectacle use and follow-up time, differences in best corrected visual acuity (VoD) and spherical equivalent (SE) between eyes were noted and compared between the groups. Best corrected visual acuity (BCVA), mean SE, astigmatism measurements were also noted and compared between amblyopic, fellow and non-amblyopic eyes.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 62 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Associated Professor, Director of Strabismus Department
• Actual Study Start Date: Sep 4, 2018
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Feb 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Group 1, astigmatic patients with amblyopia astigmatic children with amblyopia	Other: ophthalmic examination; ophthalmic examination including; best corrected visual acuity, alternating prism cover test, retinoscopy, fundus examination, ocular vergence evaluation
Group 2, astigmatic patients without amblyopia astigmatic children without amblyopia	Other: ophthalmic examination; ophthalmic examination including; best corrected visual acuity, alternating prism cover test, retinoscopy, fundus examination, ocular vergence evaluation

Outcome Measures

Primary Outcome Measures

1. ocular deviation [24 month]

   ocular deviation measured by alternate prism cover test, prism diopter

Secondary Outcome Measures

1. convergence [24 month]

   presence of convergence insufficiency at 10 cm far from visual axe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 13 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• astigmatisma ≥1,75 Diopter

Exclusion Criteria:

• systemic diseases additional ocular diseases neurological diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sakarya University Ophthalmology Department	Sakarya		Turkey	54000

Sponsors and Collaborators

• Sakarya University

Investigators

• Principal Investigator: Burcin Cakir, MD, Sakarya University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Burçin Çakır, Burcin Cakir, FICO, Sakarya University
• ClinicalTrials.gov Identifier: NCT04432181
• Other Study ID Numbers: sakarya amblyopia
• First Posted: Jun 16, 2020
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Amblyopia; Strabismus; Astigmatism

Study Results

No Results Posted as of Jun 17, 2020